Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring? Our team says it’s the best of both worlds….
ClinChoice is searching for a Senior Regulatory Affairs Associate Consultant to join one of our clients.
ClinChoice is a global full-service CRO with a strong focus on quality, professional development, and supportive culture. As a client-facing role, we are looking for confident candidates with the ability to work independently whilst establishing a high-trust environment with the client’s counterparts.
Main Job Tasks and Responsibilities:
As the Pharmaceutical Labeling Operations Manager, you will be responsible for supporting all aspects of labeling operations for dedicated clients. You will play a crucial role in ensuring compliance with regulatory requirements and delivering high-quality labeling solutions to our clients.
Key Responsibilities:
- Provide technical support and leadership to the labeling operations team, providing guidance, coaching, and feedback to ensure efficient and effective operations.
- Oversee the creation, review, and approval of labeling content, ensuring accuracy, consistency, and compliance with regulatory guidelines and product specifications.
- Manage labeling artwork design, proofreading, and finalization processes to ensure error-free and high-quality labels.
- Conduct risk assessments and implement appropriate mitigation strategies to address labeling-related risks and issues.
- Ensure adherence to relevant regulatory guidelines, such as FDA, EMA, and ICH, throughout the labeling process.
- Develop and implement labeling strategies, policies, and procedures to meet regulatory requirements and project timelines.
- Collaborate closely with cross-functional teams, including Regulatory Affairs, Clinical Operations, Quality Assurance, and Manufacturing, to ensure smooth and timely execution of labeling activities.
- Monitor industry trends and regulatory changes related to pharmaceutical labeling, and proactively implement necessary updates and improvements to labeling processes.
- Drive continuous improvement initiatives to enhance labeling operations efficiency, quality, and compliance.
- Collaborate with clients and provide expert advice and guidance on labeling requirements, best practices, and compliance matters.
- Produces quality work that meets or exceeds client expectations.
- Contribute to business strategy discussions and implement regional and global specific objectives, as appropriate.
- Lead strategic initiatives and develop implementation plans taking ownership for final results and implementing process improvements where needed.
- Participates in preparing written and presented bid developments for new clients.
- Identify opportunities for business growth to ensure on going client support and positive engagement
- Prepare and present client metrics as needed.
Education and Experience:
- Bachelor's degree in a scientific or related field. Advanced degree (Masters, PhD) is a plus.
- Minimum 3 years of experience in pharmaceutical labeling operations within a pharmaceutical industry setting.
- Strong knowledge of regulatory requirements and guidelines related to pharmaceutical labeling, including FDA, EMA, and ICH guidelines.
- Demonstrated experience in managing labeling operations, including artwork design, content creation, review processes, and regulatory compliance.
- Familiarity with labeling software and tools, such as Labeling Management Systems (LMS), Adobe Illustrator, or similar applications.
- Excellent project management skills, with the ability to prioritize tasks, manage timelines, and handle multiple projects simultaneously.
- Strong attention to detail and accuracy, with a focus on delivering high-quality labeling solutions.
- Effective leadership and team management abilities, with excellent communication and interpersonal skills.
- Proven problem-solving skills and the ability to make sound decisions under pressure.
- Demonstrated ability to manage regulatory activities and deliver against project timelines.
- Familiarity with clinical trials and knowledge of Good Clinical Practice (GCP) guidelines is desirable.
- Proficiency in using Microsoft Office Suite (Word, Excel, PowerPoint).
- Excellent oral and written communications skills as well as the ability to build cross-functional relationships and work collaboratively with other groups.
The Application Process
Once you have submitted your CV, you will receive an acknowledgement that we received it. If you have the requirements we need, you will be invited for phone interview as the first step. Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful.
Who will you be working for?
About ClinChoice
ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies. We have over 28 years of proven high-quality delivery and results across all our services, with over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific.
Our Company Ethos
Our mission drives our culture: to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Our employees are the most valuable company asset and they are the fulcrum around which all ClinChoice activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives all personnel the clear tools needed to manage both internal and client processes with the same methodology. The success of these core values is evidenced by our below industry average turnover rates.
ClinChoice is an equal opportunity employer. We have based our success on attracting, developing, and promoting talent guided by diversity and inclusivity. Our employees come from very diverse backgrounds: gender, race, beliefs, and ethnicities. We recognize this is our strength and celebrate it.
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